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Effect of erythropoietin versus control group on the short-term prognosis in newborns with hypoxic- ischemic- encephalopathy: a randomized clinical trial

Protocol summary

Study aim
To assess the effect of erythropoietin versus control group on the short-term prognosis in newborns with hypoxic- ischemic- encephalopathy
Design
This is a randomized clinical trial, phase II, in which 64 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible newborns with hypoxic- ischemic- encephalopathy referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Newborn, Hypoxic- ischemic- encephalopathy Exclusion criteria: Congenital anomalies, Gestational age less than 36 weeks, Unperforated anus, Intracranial hemorrhage
Intervention groups
Intervention group: Routine treatment plus intravenous injection of erythropoietin 1000 U/kg/day on the first, second and third days and then every other day on the fifth, seventh, and ninth days to a maximum of 6 doses Control group: Just routine treatment
Main outcome variables
Primary outcome: Seizure attacks, time of onset of consciousness, the occurrence of death, duration of hospitalization, time to start oral nutrition Secondary outcome: Drug complications such as induced topical hypothermia, bradycardia, subcutaneous, and thrombocytopenia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N334
Registration date: 2020-01-16, 1398/10/26
Registration timing: prospective

Last update: 2020-01-16, 1398/10/26
Update count: 0
Registration date
2020-01-16, 1398/10/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of erythropoietin versus control group on the short-term prognosis in newborns with hypoxic- ischemic- encephalopathy: a randomized clinical trial
Public title
Effect of erythropoietin versus control group on the short-term prognosis in newborns with hypoxic- ischemic- encephalopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newborn, Hypoxic- ischemic- encephalopathy
Exclusion criteria:
Congenital anomalies, Gestational age less than 36 weeks, Unperforated anus, Intracranial hemorrhage
Age
From 1 day old to 28 days old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.UMSHA.REC.1398.759

Health conditions studied

1

Description of health condition studied
Hypoxic ischemic encephalopathy
ICD-10 code
P91.6
ICD-10 code description
Hypoxic ischemic encephalopathy [HIE]

Primary outcomes

1

Description
Seizure attacks
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
With clinical examination

2

Description
Time of onset of consciousness
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
With clinical examination

3

Description
Occurrence of death
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
With clinical examination

4

Description
Duration of hospitalization
Timepoint
From the beginning of the intervention to two weeks thereafter
Method of measurement
Based on the medical document

5

Description
Time to start oral nutrition
Timepoint
From the beginning of the intervention until two weeks thereafter
Method of measurement
By taking a history

Secondary outcomes

1

Description
Drug complications such as induced topical hypothermia, bradycardia and subcutaneous necrosis
Timepoint
From the beginning of the intervention until two weeks later
Method of measurement
With clinical examination

2

Description
Drug complications such as thrombocytopenia
Timepoint
From the beginning of the intervention up to two weeks later
Method of measurement
By laboratory tests

Intervention groups

1

Description
Intervention group: Routine treatment plus intravenous injection of erythropoietin 1000 U/kg/day on the first, second and third days and then every other day on the fifth, seventh, and ninth days to a maximum of 6 doses
Category
Treatment - Drugs

2

Description
Control group: Just routine treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr Tayebeh Ghalandari Navideh
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
dr.ghalandari1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Ghalandari Navideh
Position
Resident of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 911 432 1196
Email
dr.ghalandari1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Behnaz Basiri
Position
Podiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
b.basiri@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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